This invention relates to doppler catheters and, in particular, to an improved catheter adapted to measure instantaneous blood flow.
Blood flow measurements are useful as an indicator of the cardiovascular control mechanism that regulates flow to all organs and tissues. The measurement of blood flow allows an assessment of various interactions commonly used in modern medical practice to alter cardiac output and the functioning of the heart.
A catheter is an elongated tube-like device containing one or more hollow channels ("lumens") which is inserted into a blood vessel. Early catheters were developed to measure the pressure in an artery or vein. These catheters were filled with fluid allowing transmission of pressure from a hole at the catheter's tip ("distal" end) to a pressure measuring device ("manometer") at the end of the catheter outside the body (the "proximal" end). Later catheters incorporated one or more transducers at the distal end which would transmit a signal down the catheter lumen to a measuring device at the proximal end. These catheters were developed to measure volumetric blood flow and blood flow velocity.
A balloon wedge pressure catheter is used to measure pressures on the left side of the heart with a catheter inserted into the right side of the heart. This is done by advancing the catheter through the right side of the heart into the main pulmonary artery and into a pulmonary artery branch vessel. A balloon near the tip of the catheter is then inflated to block the vessel, thereby blocking pressures from the right side of the heart. The pressures measured by the tip of the catheter are that of the very distal pulmonary artery branch which is in direct communication with the pulmonary veins and which, in turn, reflect pressures on the left side of the heart.
Methods for measuring mean volumetric blood flow in man include thermal dilution, dye dilution, and "Fick" oxygen consumption methods. More recent devices have been developed to measure the instantaneous flow of blood in a vessel or artery. These include methods used to measure instantaneous flow by measuring changes in a concentric magnetic field across the blood vessel. To generate the concentric magnetic field requires either a cuff surgically placed around the vessel or a catheter precisely centered in the middle of the blood vessel.
One method for centering an electromagnetic-type catheter is to use an umbrella-like spring having a number of "V"-shaped spring elements with one end of the "V" coupled to the catheter and the other end coupled to a movable collar on the catheter. By moving the collar outwardly, the springs are made to expand and extend outward away from the catheter until the blood vessel walls are contacted. By using a number of these springs around the catheter, the catheter tip will be centered in the middle of the blood vessel. Such a centering device is disclosed in an article entitled "Registration of Phasic Changes of Bloodflow by Means of a Catheter-type Flow Meter," H. Piper, The Review of Scientific Instruments, Vol. 29, No. 11, p. 965 (November, 1958).
Techniques for measuring volumetric blood flow require the determination of the diameter of the blood vessel in order to determine the total volume of blood flow through the vessel itself. One method of determining the diameter is similar to the above-described centering device. A number of hinged braces near the end of a catheter tip are extended outwardly when a cuff to which they are attached slides along the catheter length. When these braces contact the blood vessel walls, a signal proportional to the diameter of the blood vessel is produced and sensed. Such a mechanism is disclosed in an article entitled "Catheter-Tip Gauge for Measuring Blood Flow Velocity and Vessel Diameter in Dogs," Piper and Paul, Journal of Applied Physiology, Vol. 24, No. 2, p. 259 (February, 1968).
Positioning problems may arise when a flow transducer is desired to be placed at the entrance to a small blood vessel branching off of a larger blood vessel. One method for accomplishing this involves attaching a wire to the end of the catheter similar to the bow string of a bow and arrow set. The transducer is placed at the center of that portion of the catheter directly opposite the wire that will be bowed. The catheter is then inserted into the main blood vessel until the transducer is adjacent to the entrance of the smaller blood vessel. The wire can then be pulled, thereby bowing the catheter and forcing the transducer against the entrance to the smaller blood vessel. See "An Electromagnetic Catheter-Flow Meter," Kolin and Archer, Circulation Research, p. 889 (December, 1967).
A doppler ultrasonic technique for measuring blood flow velocity uses a transmitter to transmit ultrasound across a blood vessel and a receiver to detect the change in frequency and phase shift of the reflected ultrasound signals. The measured frequency change is due to the movement of the blood cells which reflect the signals ("Doppler effect").
In one type of doppler flow meter ("continuous wave"), two transducers are used. One transducer continuously transmits ultrasound signals and the other continuously receives the reflected ultrasound signals. A weighting technique can then be used with readings from this type of doppler flow meter to determine the average velocity.
A pulsed-wave doppler technique uses a single crystal transducer with the received signal being sampled at certain specified intervals. These intervals correspond to different fixed positions across the blood vessel. The intervals are determined by the amount of time it takes the ultrasound wave to travel to a particular fixed position and return. Thus, the velocity at a series of points across the diameter of a blood vessel ("sample volumes") can be accurately and instantaneously determined.
The positioning of a pulsed-wave doppler transducer in a blood vessel is critical since the distribution of velocity across a vessel ("velocity profile") may not be uniform and a fixed reference is needed in order to measure these different velocities across the diameter of the entire blood vessel. The positioning of the catheter at the center of a blood vessel, as for electromagnetic transducers, is suboptimal because the doppler transducer measures velocity in a linear distribution resulting in the measurement of only the maximum velocity at the center of the blood vessel or some portion of the entire velocity profile. In order to determine the true volumetric rate of flow, the average velocity (obtained from the entire velocity profile) and vessel cross-sectional area (obtained from the vessel diameter) must be known. Both the velocity profile and diameter may be determined using a pulsed wave doppler transducer, if the transducer is placed along one vessel wall and the transmitted ultrasound signal is directed through the blood vessel diameter. One method of accomplishing this is through the use of an external collar containing the doppler transducer which is surgically implanted around the blood vessel. Such a collar is described in a Ph.D. dissertation by James Knutti of Stanford University entitled "Totally Implantable Bidirectional Pulsed Doppler Blood Flow Telemetry: Integrated Ultrasonic Receiver, Diameter Detection, and Volume Flow Estimation" (July, 1977).
In view of the limitations of known catheters, a need exists for an improved catheter having a positioning device for positioning the catheter intravenously against one of the walls of the blood vessel in which blood flow velocity is to be measured.